Quality Applications Spec

Weil Group • Juncos, PR

6d • Onsite

About The Position

Simplrea project Role: requires: Availability to work extended shifts (8- 12 hours per shift) Availability to work weekends (Saturday and/or Sundays) Availability to work Holidays as require Availability to work first and / or second shift (If require) mainly first shift Minimum 2 years in experience in Process Validation and / Computer System Validations 1 Quality Engineer (QE) from Client will approve all documentation Use Client Quality Systems & Validation Templates Education: Engineering Degree Years of experience: 2 +plus year in validation process Position will be onsite/full-time Must have: Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory) Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing) Experience with Risk management documentation: pFMEAs Basic knowledge in statistics (preferably using Minitab) Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence) Engineering degree: Mechanical, Electrical or Chemical preferred. Preferences: Experience investigating manufacturing operations events in support to product disposition Experience assessing and tracing manufacturing defects/rejects trends Knowledge in Medical Devices regulations Experience working and executing Design transfer activities Weil Group is proud to be an Equal Employment Opportunity Employer.

Requirements

• Availability to work extended shifts (8- 12 hours per shift)
• Availability to work weekends (Saturday and/or Sundays)
• Availability to work Holidays as require
• Availability to work first and / or second shift (If require) mainly first shift
• Minimum 2 years in experience in Process Validation and / Computer System Validations
• Engineering Degree
• 2 +plus year in validation process
• Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
• Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing)
• Experience with Risk management documentation: pFMEAs
• Basic knowledge in statistics (preferably using Minitab)
• Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)
• Engineering degree: Mechanical, Electrical or Chemical preferred.

Nice To Haves

• Experience investigating manufacturing operations events in support to product disposition
• Experience assessing and tracing manufacturing defects/rejects trends
• Knowledge in Medical Devices regulations
• Experience working and executing Design transfer activities

Responsibilities

• Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
• Define validation strategies (e.g requirements flow down from design to manufacturing)
• Risk management documentation: pFMEAs
• Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees